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FDA 510(k)

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS

K-Number: K852804 · 1985-10-15

ApplicantMedcyc. Corp.
Decision Date1985-10-15
Product CodeIWL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS is the device name listed in this FDA 510(k) record. The listed applicant is Medcyc. Corp.. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K852804. The device is classified under product code IWL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS?

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is Medcyc. Corp.. The 510(k) number is K852804.

When did MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS receive FDA 510(k) clearance?

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS received FDA 510(k) clearance on 1985-10-15, under 510(k) number K852804.

Who is the listed applicant for MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS?

The FDA 510(k) record lists Medcyc. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS?

The FDA product code for MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS is IWL.

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Related Devices (Code: IWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063691NEUTRON THERAPY SYSTEMNorthern Illinois Univ. OutreachK812337ISOCENTRIC NEUTRON THERAPY SYSTEMSThe Cyclotron Corp.K811778MODEL 4100 14 MEV NEUTRON GEN. THERAPYThe Cyclotron Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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